GMP Training Course Inspections from an industry perspective 20-21 - PowerPoint PPT Presentation

GMP Training Course Inspections from an industry perspective 20-21 October 2009 Fiona Routley – MHRA Inspector (UK)

Objective • To provide an insight into how arranged inspections are prepared and managed. • To share my industry experience of inspections. • To discuss potential areas of conflict.

Preparation • A positive inspection outcome is crucial to the reputation of the company as an ethical manufacturer • Planning prevents poor performance • Corporate Policy & Local Procedures • Personnel will be trained • ‘How to conduct yourself in an inspection’

Preparation • Scope & Timing • Communication Cascade • Inspector Intelligence • Corporate Audit • ‘4 Week Plan’ Initiation • Site / Areas within scope & other potential areas

Site Inspection Team Business Process Owner Initial Action Plan Laboratory (Analytical Set up weekly ‘Plan Do Review’ meetings Microbiology) Global Check profile of the inspectors Systems / Technical Group Establish contacts list Review site inspection history QMS BPO Check availability of primary / deputy Complaints Engineering contacts APR Stability Communicate inspection dates& scope to BPO other teams. Arrange their availability as appropriate Inspection Current Issue Management & Position QMS BPO Packing statements Release Regulatory Inspection Strategy - Number inspectors vs. War Room & QMS BPO personnel Deviation Production Launch Event Validation Area 1 Change Initiate weekly area tours Computer Control Validation Communication with Leadership Team

Local Inspection Team • Typical Representation • Local individual 4 week plans will be initiated QA Production Engineering Inspection Lead Support Technical Functions QC

Week 4 Action Establish contact with site inspection team Establish contacts list Check availability of primary / deputy contacts Check that contacts are trained. ‘How to be behave in an inspection’ – arrange if necessary Generate list of key SOPs & Forms Review and update SOPs, as necessary Check any existing Position Statements vs. current situation Review any open deviations and progress or document rationale for being open Review any audit actions & any actions required before inspection? Review change control – any significant changes relevant to the inspection? APR /PQR status Review key system personnel training records / job descriptions Review training material and update if necessary Initiate weekly area tours Generate lists of Deviations / Change Controls Collate validation documents

Week 3 Action Review week 4 actions for completion Review and update relevant system access Determine (and provide if necessary) whether war room needs any additional system access. Review and update expert packages Review of documentation – any updates required? Send contacts list (with contact numbers) to the War Room Review controlled document binders (SOPs, awareness forms, reading, housekeeping of documents) Review Key Investigations Generate list of Technical Documents and send to War Room Assess requirements for documents i.e. on site or off site from archive Start to populate war room with controlled documents and generate document inventory

Week 2 Action Review week 3 actions for completion Check requirement for demo PC and printers Confirm requirements for tours, who will do them, route, etc ? Transfer Hard copies of Expert Packages to the War Room Ensure a ‘demo’ PC is available, if required Walk Route with QA/QP – Mock Inspection

Week 1 Action Review week 2 actions for completion Send inspection relevant user messages Expert Packages and SOP content familiarisation Communicate Inspection Plan to team, if known Walk Route with QA/QP – Mock Inspection

Expert Packages • Presentation • Describes the company approach • High level overview • Sets the scene • Lists key procedures • Is it an introduction, a way in or a stalling tactic ?

Inspection Personnel • Head of QA • QP • Senior Management – Production • Secretary / Scribe • Runners • Back Room Personnel • Key Contacts & Deputies Can have up to 50+ personnel involved each day

Inspection Control Centre The HUB/ The Control Room / The War Room • Dedicated communication links • Electronic Request System – ( Back up paper request system & sufficient runners ) • Access to all systems • Booking In / Out Process & Review Process – Status & Location of every document requested tracked throughout the inspection – Documents reviewed Risks ? Where next ? • Processes trailed and tested prior to inspection. • Personnel dedicated to inspection, removed from routine duties

Opening Meeting • Agenda • Confirm Scope • Confirm key personnel are available • Company Introductions • Company Presentation / Overview • Ascertain initial documentation requests

Inspection – Week 0 • Be prepared for all aspects to be inspected: – Quality Management System Review – Facility Tours – Documentation Review – System Demonstrations – QC testing to be observed e.g. Sterility Test – Access to controlled areas – Personnel Interviews

Inspection – Week 0 Re-communicate Inspection Plan to team • Communication is key ! – Stand down / up – Location of Inspector – Daily Debriefs / Summary reports – Primary contacts / Deputies availability – Inpsection Wrap Up Mtg • Personnel available and suitably prepared to represent company

Closing Meeting • Deficiencies should hopefully be clear and apparent • These should have been openly discussed • Negotiation NO! --- Correct Misconceptions YES

Deficiencies & Post Inspection Follow Up • Correct as many deficiencies during inspection Post Inspection: Deficiency Assessed Response Collated & Holistically Assessed Reviewed by senior management and endorsed Reviewed by Corporate QA Endorsement – Global Implications ? Finalised and Approved Response Communicated back to relevant Health Authority Deficiency Action Plan implemented & tracked to completion

Areas of Conflict • Controlling ? – Agenda, Availability Personnel • Time Wasting ? – Getting on site – ‘the security video’ – The lengthy company overview presentation – Over use of expert packages – Repeated documentation requests

Areas of Conflict • Complexity – Procedures – Terminology/ Jargon • Corporate QA presence – Not allowing site personnel to respond i.e. theory vs. actual – Defending corporate position • Number of people involved

Some of the Challenges • The number documents that can be requested • Historical documentation – off site archives – Timelines for retrieval • Access to controlled areas ? – Allow access or follow standard procedures • Personality Conflicts QA/Inspector

Thank You for Listening Questions ?